Abilify Maintena, Aristada, Abilify Asimtufii, Abilify, Abilify MyCite, Aristada Initio
Synonyms :
aripiprazole
Class :
2nd generation Anti psychotics, Antimaniac agents
No data available for drug.
Actions and Spectrum:
The mechanism of action of aripiprazole is complex and not fully understood. It acts as a partial agonist at serotonin 5-HT1A receptors and dopamine D2 and an antagonist at serotonin 5-HT2A receptors. This unique pharmacological profile is thought to contribute to aripiprazole’s efficacy in treating both positive and negative symptoms of schizophrenia and mood stabilization in bipolar disorder.
In addition to its direct effects on dopamine and serotonin receptors, aripiprazole also affects other neurotransmitter systems, including noradrenaline and histamine receptors.
The spectrum of activity of aripiprazole includes the treatment of schizophrenia, bipolar disorder (both mania and depression), and major depressive disorder. It has also been used off-label to treat anxiety disorders, obsessive-compulsive disorder, and autism spectrum disorder.
Abilify The MyCite system consists of the following elements:
aripiprazole capsule contains an ingestible event marker (IEM) sensor
MyCite patch is a wearable sensor that sends information to a smartphone after detecting the signal from an IEM sensor after consumption.
A compatible smartphone is used to access the MyCite APP, a smartphone application (app) that shows patient information. Portal on the web enables medical staff and patients to share information.
Orally
Initial oral dosing of 10–15 mg/day; possible dosage increases of up to two weeks at every single dose strength; maximum oral dosing of 30 mg/day when given in tablet form; increased effectiveness above 15 mg/day not seen.
Abilify Maintena
First-time users of aripiprazole should start with 400 mg administered intramuscularly (IM) once monthly.
Before beginning therapy with Abilify Maintena, it is essential to determine whether you can take oral aripiprazole; this process may take up to two weeks.
After the initial injection, patients who have shown tolerance to aripiprazole should take 10 to 20 mg of the drug orally daily for 14 days.
Patients who are stable or tolerant to aripiprazole receive 400 mg intramuscularly (IM) once per month.
The monthly dose should be administered only 26 days after the previous injection. Consider reducing the monthly dose to 300 mg if an adverse reaction occurs.
Aristada Initio (single intramuscular dose)
Aristada is recommended for the initial treatment of schizophrenia when taken with oral aripiprazole.
Aristada may be started with a single dosage or restarted with a single dose when a dose was skipped.
Aristada Initio therapy should only be started if aripiprazole oral solution tolerance has been established; this may take up to 2 weeks.
aripiprazole orally (PO) should be tolerated before starting Aristada intramuscularly (IM).Aristada Initio 675 mg intramuscularly with aripiprazole 30 mg orally.
Do not take more than one dosage of Aristada Initio at a time. The first Aristada extended-release intramuscular injection may be administered on the exact same day as Aristada Initio or up to 10 days later.
Aristada (intramuscular monthly once )
Tolerance should be established with oral aripiprazole before starting Aristada; properly evaluating tolerance may take up to 2 weeks.
Aristada's first dosage should be based on the present aripiprazole oral dose; coadminister aripiprazole for 21 days orally
10 mg/day orally: Administer 441 mg intramuscularly once a month
15 mg/day orally: 662 mg intramuscular once a month or 882 mg intramuscular every six weeks, or 1064 mg intramuscular every two months
≥20 mg/day orally: 882 mg intramuscularly once monthly
Abilify Asimtufii (intramuscular every two months)
aripiprazole has never been used
Before starting 960 mg intramuscularly every two months, evaluate oral aripiprazole for tolerability. Tolerability testing may take up to 2 weeks. For 14 days following the first injection, individuals with known aripiprazole tolerance should continue taking oral aripiprazole (10 to 20 mg/day) or other antipsychotics orally.
With oral antipsychotics, Administer the initial dosage in combination with oral aripiprazole 10-20 mg orally for 14 consecutive days. Another oral antipsychotic that is stable (and is known to tolerate aripiprazole): For 14 days, provide the initial injection along with an oral antipsychotic.
Patients on Abilify Maintena In patients taking Abilify Maintena (one monthly dose)
Take Abilify Asimtufii 960 mg once every two months instead of the next scheduled injection of Abilify Maintena.
Provide the first injection of Abilify Asimtufii instead of the second or subsequent dose of Abilify Maintena.
If the 960-mg Abilify Asimtufii dose causes unpleasant responses, the dosage may be reduced to 720 mg once every two months. Abilify Asimtufii may be given up to 2 weeks before or after the 2-month prescribed time point.
Orally
Initial dose of 15 mg/day orally; may be increased progressively; a maximum daily dose of 30 mg/day.
Adjunct to lithium or valproate:10 to 15 mg/day orally initially; 15 mg/day is the recommended daily dose; may be progressively increased; Do not exceed 30 mg/day.
Continue the stabilization dosage for up to 6 weeks; therapy beyond six weeks has not been investigated.
Abilify Maintena
Patients without prior exposure to aripiprazole should begin with a monthly 400 mg Intramuscular dose.
Only a healthcare expert should administer this medication through deep intramuscular injection into the deltoid or gluteal muscle.
Establish tolerance with aripiprazole orally before beginning Abilify Maintena medication; thoroughly evaluating tolerability may take up to 2 weeks.
In patients with known aripiprazole tolerance, continue aripiprazole orally (10 to 20 mg/day) or other oral antipsychotics for 14 days following the first injection.
Patients who are stable or tolerant to aripiprazole receive 400 mg intramuscularly (IM) once per month. Administer monthly dose no earlier than 26 days after the previous injection. Consider reducing the monthly dose to 300 mg if an adverse reaction occurs.
Abilify Asimtufii (intramuscular every two months)
Never consumed aripiprazole
Establish oral aripiprazole tolerability before initiating 960 mg Intramuscular every two months.
Up to two weeks may be required to assess tolerability in patients with known aripiprazole tolerance thoroughly; continue oral aripiprazole (10 to 20 mg/day) or other antipsychotics Orally for 14 days after the first injection.
Orally antipsychotic-treated
Administer the initial dose of oral aripiprazole along with 10 to 20 mg for 14 consecutive days. Known to tolerate aripiprazole and stable on another oral antipsychotic First injection along with oral antipsychotic medication for 14 consecutive days
Treatment with Abilify Maintena
Administration of Abilify Asimtufii 960 mg every two months instead of the next planned injection of Abilify Maintena (once monthly dose) is recommended for patients on Abilify Maintena. Administer the first injection of Abilify Asimtufii instead of the second or subsequent injection of Abilify Maintena.
If adverse reactions occur with Abilify Asimtufii 960 mg, the dosage may be reduced to 720 mg every two months.
May administer Abilify Asimtufii up to 2 weeks before or after the 2-month timepoint.
Dosage Modifications (Aristada)
There are no dose adjustments if CYP450 modulators are administered for less than two weeks.
Potent CYP3A4 inhibitor for more than two weeks
Lower the dosage to the next lowest strength. If 441 mg is tolerated, no dose change is required. Poor metabolizers of CYP2D6: Reduce the dose from 662 mg, 882 mg, or 1064 mg to 441 mg; if tolerated, there is no need to modify the dosage for individuals using 441 mg.
For more than two weeks, a potent CYP2D6 inhibitor was used:
Lower the dosage to the next lowest strength. If 441 mg is tolerated, no dose change is required.
Poor CYP2D6 metabolizers: There is no need to alter the dosage.
Both powerful CYP3A4 and CYP2D6 inhibitors were used for over two weeks:
Patients taking 662 mg, 882 mg, or 1064 mg should avoid using it.
If 441 mg is tolerated, no dose change is required.
CYP3A4 inducers for more than two weeks:
There is no need to change the dosage to 662 mg, 882 mg, or 1064 mg. Increase the dosage from 441 mg to 662 mg.
Dosage Modifications (Aristada inito)
Poor CYP2D6 metabolizers, potent CYP3A4 inhibitors, and potent CYP3A4 inducers: Avoid using
Hepatic Impairment
Mild-to-severe (Child-Pugh score 5-15): There is no need for a dose change.
Renal Impairment
Mild-to-severe (GFR 15-90 mL/min): No dose changes are required.
Dosage Modifications (Abilify Asimtufii)
Poor CYP2D6 metabolizers
Poor CYP2D6 metabolizers: 720 mg every two months
Avoid usage if you are a known CYP2D6-poor metabolizer taking a CYP3A4 inhibitor.
Coadministration of CYP2D6 inhibitors-Patients on 960 mg should be reduced to 720 mg every two months.
Coadministration of CYP3A4 inhibitors-Patients on 960 mg should be reduced to 720 mg every two months.
Patients using 960 mg: Avoid coadministration with strong CYP2D6 and CY3A4 inhibitors.
Patients using 960 mg should avoid coadministration with potent CY3A4 inducers.
<13 years: Safety and efficacy not established
13 to 17 years: Initial oral dosage of 2 mg/day, followed by a rise to 5 mg/day after two days, and then, after an additional two days, a possible increase to the recommended dose of 10 mg/day;
maintenance dose: 10 to 30 mg/day
10 to 17 years: 2 mg/day orally at first, followed by a rise to 5 mg/day after two days, and then, after an additional two days, to the recommended dosage of 10 mg/day, with consecutive doses potentially increasing by 5 mg/day;
maintenance dose: 10 to 30 mg/day
10 to 17 years: 2 mg/day orally at first, followed by a rise to 5 mg/day after two days, and then, after an additional two days, to the recommended dosage of 10 mg/day, with consecutive doses potentially increasing by 5 mg/day;
maintenance dose: 10 to 30 mg/day
<6 years: Safety and efficacy not established
6 to 17 years:
Initial dose: 2 mg/day orally; increase progressively at 1-week intervals to 5 mg/day; may gradually increase whenever needed to 10 mg/day or higher; maximum dose: 15 mg/day
<6 years: Safety and efficacy not established
6 to 18years (<50 kg):
Start with 2 mg/day orally (PO), increasing to 5 mg/day after two days. If patients are not experiencing good suppression of tics at 5 mg/day, they may escalate to 10 mg/day. Dosage adjustments should be made progressively at no less than one-week intervals.
6 to 18years (>50 kg):
Take 2 mg orally daily for two days, 5 mg for five days, and 10 mg on day 8. The daily dosage can be increased to 20 mg for patients who do not attain optimal tic control. Dosage adjustments should be made progressively in 5 mg/day increments at no less than one-week intervals.
Dose Adjustments
Poor metabolizers and cytochrome-P 450 inhibitors
Poor metabolizers of CYP2D6: Administer half of the suggested dosage.
Known CYP2D6 poor metabolizers concurrently receiving potent CYP3A4 inhibitors: Administer one-fourth of the prescribed dose (i.e., a 75% reduction).
Potent inhibitors of CYP2D6 or CYP3A4: Administer half the suggested
dose
Strong CYP2D6 AND CYP3A4 inhibitors: Administer a quarter of the recommended dose (or a 75% reduction in dosage).
Strong inducers of CYP3A4: double the recommended dose over 1 to 2 weeks.
Refer adult dosing
Frequency defined
>10%
Headache (27%)
Insomnia (18%)
Nausea and vomiting (11-15%)
Lightheadedness (11%)
Weight gain (8-30%)
Agitation (19%)
Anxiety (17%)
Akathisia (10-13%)
Constipation (10-11%)
1-10%
Dyspepsia (9%)
Fatigue (6%)
Tremor (6%)
Extrapyramidal disorder (5%)
Musculoskeletal stiffness (4%)
Blurred vision (3%)
Pain (3%)
Rash
Rhinitis
Dizziness (10%)
Somnolence (5-8%)
Restlessness (6%)
Dry mouth/xerostomia (5%)
Orthostatic hypotension (1-5%)
Abdominal discomfort (3%)
Cough (3%)
Myalgia (2%)
<1%
Autonomic instability
Hyperpyrexia
Neuroleptic malignant syndrome (NMS)
Tardive dyskinesia
Altered mental status
Dysphagia
Muscle rigidity
Seizure
Post-marketing reports
Hiccups
Oculogyric crisis
Pathological gambling
Falls
Black box warning:
The black box warning for aripiprazole states that it may increase mortality in the elderly with dementia-related psychosis.There is an elevated mortality risk in elderly people treated with antipsychotic medicines such aripiprazole for dementia-related psychosis. Dementia-related psychiatric symptoms cannot be treated with aripiprazole.
Suicidal ideation and behaviour are also more likely to occur in children, adolescents, and young adults using aripiprazole for the treatment of major depressive disorder or other psychiatric conditions. Close monitoring of patients receiving aripiprazole is necessary, particularly those with a history of suicidal ideation or behavior.
It is essential to note that a black box warning does not necessarily mean that medication cannot be used. It should carefully consider the potential risks and benefits and only use them when the benefits outweigh the risks.
Contraindications/caution:
Contraindications:
Hypersensitivity: aripiprazole is contraindicated in patients with a known hypersensitivity to the drug or its components.
Elderly patients with dementia-related psychosis: As mentioned earlier, aripiprazole is not approved for treating dementia-related psychosis, and its use may increase the risk of mortality in elderly patients.
Uncontrolled seizures: aripiprazole may lower the seizure threshold and increase the risk of seizures, especially in patients with a history of seizures. Therefore, aripiprazole is contraindicated in patients with uncontrolled seizures.
Pregnancy and breastfeeding: The safety of aripiprazole in pregnancy and breastfeeding is not established. aripiprazole should only be used in pregnant or breastfeeding women if the potential benefits outweigh the risks.
Concomitant use with potent CYP3A4 inhibitors: aripiprazole is primarily metabolized by the CYP3A4 enzyme system. The concomitant use of aripiprazole with potent CYP3A4 inhibitors, such as ketoconazole and clarithromycin, may increase aripiprazole’s exposure and increase the risk of adverse effects.
Caution:
Cardiovascular disease: aripiprazole may cause orthostatic hypotension and blood pressure drop upon standing up. This effect may be more pronounced in patients with cardiovascular disease. Therefore, caution is advised when using aripiprazole in patients with a history of cardiovascular disease.
Diabetes: aripiprazole may cause hyperglycemia (high blood sugar), worsening diabetes. Patients with diabetes should be closely monitored when using aripiprazole.
Neuroleptic Malignant Syndrome (NMS): NMS is a rare but potentially life-threatening adverse effect of antipsychotic medications such as aripiprazole. Patients should be monitored for symptoms of NMS, such as fever, muscle rigidity, and altered mental status.
Seizures: aripiprazole may lower the seizure threshold and increase the risk of seizures, especially in patients with a history of seizures.
Suicidal thoughts and behavior: aripiprazole may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders.
Pregnancy and breastfeeding: aripiprazole should only be used in pregnant women if the potential benefits outweigh the risks.
Hepatic impairment: aripiprazole is metabolized in the liver, and its exposure may be increased in patients with hepatic impairment. Therefore, caution is advised when using aripiprazole in patients with hepatic impairment.
Pregnancy consideration: Insufficient data available
Lactation: Excretion of the drug in human breast milk is known
Pregnancy category:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
aripiprazole is an atypical antipsychotic medication that works through several pharmacological mechanisms. Its primary mechanism of action is as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, meaning it activates these receptors to a lesser degree than full agonists. aripiprazole also acts as an antagonist at serotonin 5-HT2A receptors.
The partial agonist activity of aripiprazole at dopamine D2 receptors is thought to underlie its antipsychotic effects, as excessive dopamine activity is believed to contribute to psychotic symptoms. By partially activating dopamine receptors, aripiprazole can normalize dopamine activity in the brain.
The partial agonist activity of aripiprazole at serotonin 5-HT1A receptors is thought to contribute to its antidepressant effects. Activation of these receptors is associated with increased serotonin activity, which is believed to play a role in mood regulation.
The antagonistic activity of aripiprazole at serotonin 5-HT2A receptors is thought to contribute to its effects on cognition and behavior. Excessive serotonin activity at these receptors has been associated with cognitive and behavioral deficits, and antagonism of these receptors may help to facilitate these deficits.
Pharmacodynamics:
The pharmacodynamics of aripiprazole involves its effects on neurotransmitters in the brain, specifically dopamine, and serotonin. aripiprazole acts as a partial agonist at dopamine D2 receptors, which regulate movement, cognition, and emotion. By partially activating these receptors, aripiprazole can normalize dopamine activity in the brain and alleviate symptoms of psychosis, such as hallucinations and delusions.
aripiprazole also acts as a partial agonist at serotonin 5-HT1A receptors, which regulate mood and anxiety. Activation of these receptors is associated with increased serotonin activity, which is believed to play a role in mood regulation. By partially activating these receptors, aripiprazole can alleviate symptoms of depression and anxiety.
Pharmacokinetics:
Absorption
aripiprazole is well absorbed after oral administration and reaches peak plasma concentrations within 3-5 hours. The oral bioavailability of aripiprazole is approximately 87%, indicating that most of the drug is absorbed into the bloodstream.
Distribution
aripiprazole is highly protein-bound (greater than 99%), mainly to albumin and alpha-1-acid glycoprotein. It has a large volume of distribution, indicating that it distributes extensively into tissues beyond the bloodstream.
Metabolism
aripiprazole is extensively metabolized in the liver, primarily by the CYP3A4 enzyme system, to form several metabolites, including dehydroaripiprazole, which is pharmacologically active. These metabolites are less potent than the parent drug and are excreted in the urine and feces.
Excretion and Elimination
The metabolites of aripiprazole are excreted in the urine and feces. The elimination half-life of aripiprazole is approximately 75 hours, indicating that it is eliminated slowly from the body. aripiprazole is usually administered once daily, which helps to maintain steady-state concentrations in the bloodstream.
Administration:
aripiprazole is usually administered orally in tablet form, and the dose can vary depending on the condition being treated and the individual patient’s needs. The tablets are typically taken once per day, with or without food.
The starting dose of aripiprazole can vary depending on the indication. For schizophrenia in adults, the starting dose is usually 10-15 mg once daily, while for the treatment of bipolar disorder in adults, the starting dose is usually 15 mg once daily. The dose can be gradually increased as needed to achieve the desired therapeutic effect, up to a maximum daily dose of 30 mg for the treatment of schizophrenia and 25 mg for the treatment of bipolar disorder.
For treating major depressive disorder in adults, aripiprazole is usually administered as an add-on therapy to an antidepressant. The recommended starting dose is 2-5 mg once daily, with a maximum daily dose of 15 mg.
Patient information leaflet
Generic Name: aripiprazole
Why do we use aripiprazole?
aripiprazole is a medication that is primarily used to treat several psychiatric conditions, including:
Schizophrenia: aripiprazole is approved for treating schizophrenia in adults and adolescents aged 13-17. It can help to reduce symptoms such as hallucinations, delusions, and disordered thinking.
Bipolar disorder: For those with bipolar illness, aripiprazole is an authorised medication for treating mania and mixed episodes (ages 10-17). It can alleviate symptoms like agitation, impulsivity, and irritability.
Major depressive disorder: aripiprazole is approved as an add-on treatment to an antidepressant for treating the major depressive disorder in adults who have not responded adequately to antidepressant therapy alone.
Autism spectrum disorder: In children and teenagers ages 6 to 17, aripiprazole has been shown effective in reducing irritability due to autism spectrum disorder. Aggression, self-injury, and outbursts of rage are just some of the symptoms that may improve with this treatment.
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Abilify The MyCite system consists of the following elements:
aripiprazole capsule contains an ingestible event marker (IEM) sensor
MyCite patch is a wearable sensor that sends information to a smartphone after detecting the signal from an IEM sensor after consumption.
A compatible smartphone is used to access the MyCite APP, a smartphone application (app) that shows patient information. Portal on the web enables medical staff and patients to share information.
Orally
Initial oral dosing of 10–15 mg/day; possible dosage increases of up to two weeks at every single dose strength; maximum oral dosing of 30 mg/day when given in tablet form; increased effectiveness above 15 mg/day not seen.
Abilify Maintena
First-time users of aripiprazole should start with 400 mg administered intramuscularly (IM) once monthly.
Before beginning therapy with Abilify Maintena, it is essential to determine whether you can take oral aripiprazole; this process may take up to two weeks.
After the initial injection, patients who have shown tolerance to aripiprazole should take 10 to 20 mg of the drug orally daily for 14 days.
Patients who are stable or tolerant to aripiprazole receive 400 mg intramuscularly (IM) once per month.
The monthly dose should be administered only 26 days after the previous injection. Consider reducing the monthly dose to 300 mg if an adverse reaction occurs.
Aristada Initio (single intramuscular dose)
Aristada is recommended for the initial treatment of schizophrenia when taken with oral aripiprazole.
Aristada may be started with a single dosage or restarted with a single dose when a dose was skipped.
Aristada Initio therapy should only be started if aripiprazole oral solution tolerance has been established; this may take up to 2 weeks.
aripiprazole orally (PO) should be tolerated before starting Aristada intramuscularly (IM).Aristada Initio 675 mg intramuscularly with aripiprazole 30 mg orally.
Do not take more than one dosage of Aristada Initio at a time. The first Aristada extended-release intramuscular injection may be administered on the exact same day as Aristada Initio or up to 10 days later.
Aristada (intramuscular monthly once )
Tolerance should be established with oral aripiprazole before starting Aristada; properly evaluating tolerance may take up to 2 weeks.
Aristada's first dosage should be based on the present aripiprazole oral dose; coadminister aripiprazole for 21 days orally
10 mg/day orally: Administer 441 mg intramuscularly once a month
15 mg/day orally: 662 mg intramuscular once a month or 882 mg intramuscular every six weeks, or 1064 mg intramuscular every two months
≥20 mg/day orally: 882 mg intramuscularly once monthly
Abilify Asimtufii (intramuscular every two months)
aripiprazole has never been used
Before starting 960 mg intramuscularly every two months, evaluate oral aripiprazole for tolerability. Tolerability testing may take up to 2 weeks. For 14 days following the first injection, individuals with known aripiprazole tolerance should continue taking oral aripiprazole (10 to 20 mg/day) or other antipsychotics orally.
With oral antipsychotics, Administer the initial dosage in combination with oral aripiprazole 10-20 mg orally for 14 consecutive days. Another oral antipsychotic that is stable (and is known to tolerate aripiprazole): For 14 days, provide the initial injection along with an oral antipsychotic.
Patients on Abilify Maintena In patients taking Abilify Maintena (one monthly dose)
Take Abilify Asimtufii 960 mg once every two months instead of the next scheduled injection of Abilify Maintena.
Provide the first injection of Abilify Asimtufii instead of the second or subsequent dose of Abilify Maintena.
If the 960-mg Abilify Asimtufii dose causes unpleasant responses, the dosage may be reduced to 720 mg once every two months. Abilify Asimtufii may be given up to 2 weeks before or after the 2-month prescribed time point.
Orally
Initial dose of 15 mg/day orally; may be increased progressively; a maximum daily dose of 30 mg/day.
Adjunct to lithium or valproate:10 to 15 mg/day orally initially; 15 mg/day is the recommended daily dose; may be progressively increased; Do not exceed 30 mg/day.
Continue the stabilization dosage for up to 6 weeks; therapy beyond six weeks has not been investigated.
Abilify Maintena
Patients without prior exposure to aripiprazole should begin with a monthly 400 mg Intramuscular dose.
Only a healthcare expert should administer this medication through deep intramuscular injection into the deltoid or gluteal muscle.
Establish tolerance with aripiprazole orally before beginning Abilify Maintena medication; thoroughly evaluating tolerability may take up to 2 weeks.
In patients with known aripiprazole tolerance, continue aripiprazole orally (10 to 20 mg/day) or other oral antipsychotics for 14 days following the first injection.
Patients who are stable or tolerant to aripiprazole receive 400 mg intramuscularly (IM) once per month. Administer monthly dose no earlier than 26 days after the previous injection. Consider reducing the monthly dose to 300 mg if an adverse reaction occurs.
Abilify Asimtufii (intramuscular every two months)
Never consumed aripiprazole
Establish oral aripiprazole tolerability before initiating 960 mg Intramuscular every two months.
Up to two weeks may be required to assess tolerability in patients with known aripiprazole tolerance thoroughly; continue oral aripiprazole (10 to 20 mg/day) or other antipsychotics Orally for 14 days after the first injection.
Orally antipsychotic-treated
Administer the initial dose of oral aripiprazole along with 10 to 20 mg for 14 consecutive days. Known to tolerate aripiprazole and stable on another oral antipsychotic First injection along with oral antipsychotic medication for 14 consecutive days
Treatment with Abilify Maintena
Administration of Abilify Asimtufii 960 mg every two months instead of the next planned injection of Abilify Maintena (once monthly dose) is recommended for patients on Abilify Maintena. Administer the first injection of Abilify Asimtufii instead of the second or subsequent injection of Abilify Maintena.
If adverse reactions occur with Abilify Asimtufii 960 mg, the dosage may be reduced to 720 mg every two months.
May administer Abilify Asimtufii up to 2 weeks before or after the 2-month timepoint.
Dosage Modifications (Aristada)
There are no dose adjustments if CYP450 modulators are administered for less than two weeks.
Potent CYP3A4 inhibitor for more than two weeks
Lower the dosage to the next lowest strength. If 441 mg is tolerated, no dose change is required. Poor metabolizers of CYP2D6: Reduce the dose from 662 mg, 882 mg, or 1064 mg to 441 mg; if tolerated, there is no need to modify the dosage for individuals using 441 mg.
For more than two weeks, a potent CYP2D6 inhibitor was used:
Lower the dosage to the next lowest strength. If 441 mg is tolerated, no dose change is required.
Poor CYP2D6 metabolizers: There is no need to alter the dosage.
Both powerful CYP3A4 and CYP2D6 inhibitors were used for over two weeks:
Patients taking 662 mg, 882 mg, or 1064 mg should avoid using it.
If 441 mg is tolerated, no dose change is required.
CYP3A4 inducers for more than two weeks:
There is no need to change the dosage to 662 mg, 882 mg, or 1064 mg. Increase the dosage from 441 mg to 662 mg.
Dosage Modifications (Aristada inito)
Poor CYP2D6 metabolizers, potent CYP3A4 inhibitors, and potent CYP3A4 inducers: Avoid using
Hepatic Impairment
Mild-to-severe (Child-Pugh score 5-15): There is no need for a dose change.
Renal Impairment
Mild-to-severe (GFR 15-90 mL/min): No dose changes are required.
Dosage Modifications (Abilify Asimtufii)
Poor CYP2D6 metabolizers
Poor CYP2D6 metabolizers: 720 mg every two months
Avoid usage if you are a known CYP2D6-poor metabolizer taking a CYP3A4 inhibitor.
Coadministration of CYP2D6 inhibitors-Patients on 960 mg should be reduced to 720 mg every two months.
Coadministration of CYP3A4 inhibitors-Patients on 960 mg should be reduced to 720 mg every two months.
Patients using 960 mg: Avoid coadministration with strong CYP2D6 and CY3A4 inhibitors.
Patients using 960 mg should avoid coadministration with potent CY3A4 inducers.
<13 years: Safety and efficacy not established
13 to 17 years: Initial oral dosage of 2 mg/day, followed by a rise to 5 mg/day after two days, and then, after an additional two days, a possible increase to the recommended dose of 10 mg/day;
maintenance dose: 10 to 30 mg/day
10 to 17 years: 2 mg/day orally at first, followed by a rise to 5 mg/day after two days, and then, after an additional two days, to the recommended dosage of 10 mg/day, with consecutive doses potentially increasing by 5 mg/day;
maintenance dose: 10 to 30 mg/day
10 to 17 years: 2 mg/day orally at first, followed by a rise to 5 mg/day after two days, and then, after an additional two days, to the recommended dosage of 10 mg/day, with consecutive doses potentially increasing by 5 mg/day;
maintenance dose: 10 to 30 mg/day
<6 years: Safety and efficacy not established
6 to 17 years:
Initial dose: 2 mg/day orally; increase progressively at 1-week intervals to 5 mg/day; may gradually increase whenever needed to 10 mg/day or higher; maximum dose: 15 mg/day
<6 years: Safety and efficacy not established
6 to 18years (<50 kg):
Start with 2 mg/day orally (PO), increasing to 5 mg/day after two days. If patients are not experiencing good suppression of tics at 5 mg/day, they may escalate to 10 mg/day. Dosage adjustments should be made progressively at no less than one-week intervals.
6 to 18years (>50 kg):
Take 2 mg orally daily for two days, 5 mg for five days, and 10 mg on day 8. The daily dosage can be increased to 20 mg for patients who do not attain optimal tic control. Dosage adjustments should be made progressively in 5 mg/day increments at no less than one-week intervals.
Dose Adjustments
Poor metabolizers and cytochrome-P 450 inhibitors
Poor metabolizers of CYP2D6: Administer half of the suggested dosage.
Known CYP2D6 poor metabolizers concurrently receiving potent CYP3A4 inhibitors: Administer one-fourth of the prescribed dose (i.e., a 75% reduction).
Potent inhibitors of CYP2D6 or CYP3A4: Administer half the suggested
dose
Strong CYP2D6 AND CYP3A4 inhibitors: Administer a quarter of the recommended dose (or a 75% reduction in dosage).
Strong inducers of CYP3A4: double the recommended dose over 1 to 2 weeks.
